July 9, 2019

First-Time Generics Approved for Two Pain Medications

The FDA recently approved the first generic versions of two different pain medications that have previously only been available as brand drugs. As pain medications, these drugs could appear in workers’ comp claims, and the availability of generic versions could provide significant cost savings without any alterations to clinical impact.

Ultram (tramadol hydrochloride) tablets are for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. An abbreviated new drug application (ANDA) was approved for tramadol hydrochloride tablets in late June.

This generic approval is for both 50 mg and 100 mg tablets. The FDA noted that while Ultram 100 mg tablets were discontinued, the reasons for discontinuation were not for reasons of safety or effectiveness.

Dyloject (diclofenace sodium) injections are for the management of mild to moderate pain, or for the management of moderate to severe pain alone or in combination with opioid analgesics. An ANDA for diclofenac sodium injections was approved in mid-June.

This generic approval is for 37.5 mg/mL singe-dose vials. The FDA noted that while Dyloject 37.5 mg/mL singe-dose vials were discontinued, the reasons for discontinuation were not for reasons of safety or effectiveness.

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